Merck and Ridgeback announce the filing of an emergency filing with the U.S. FDA for molnupiravir, an investigational oral antiviral drug used to treat mild to moderate COVID-19 in at-risk adults
Details Category: Small Molecules Posted on Monday, October 11, 2021 6:43 PM Hits: 210
If approved, molnupiravir could become the first oral antiviral drug to treat COVID-19. be
Filings with regulators worldwide in progress
KENILWORTH, NJ & MIAMI, FL, USA I October 11, 2021 I Merck (NYSE: MRK), known outside the United States and Canada as MSD, and Ridgeback Biotherapeutics announced today that Merck has filed an EEA for Molnupiravir, an oral drug, with the US Food and Drug Administration (FDA) Investigational Compound, Submitted Antiviral medicine to treat mild to moderate COVID-19 in adults who are at risk of progressing to severe COVID-19 and / or being hospitalized. The companies are working actively with regulatory authorities around the world to submit applications for emergency use or market approval in the coming months.
The application is based on positive results from a planned interim analysis of the Phase 3 MOVe-OUT clinical trial investigating molnupiravir in non-hospitalized adult patients with mild to moderate COVID-19 who are at risk of progression to severe COVID -19 existed. 19 and / or hospitalization. In the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients receiving molnupiravir were either hospitalized or died by day 29 post randomization (28/385), compared with 14.1% of patients receiving placebo (53/377); p = 0.0012. No deaths were reported by day 29 in patients receiving molnupiravir compared to 8 deaths in patients receiving placebo. The incidence of any adverse events was similar in the molnupiravir and placebo groups (35% and 40%, respectively). The incidence of drug-related adverse events was also comparable (12% and 11%) and fewer patients in the molnupiravir group discontinued therapy due to an adverse event compared to the placebo group (1.3% and 3.4%) .
“The extraordinary impact of this pandemic requires us to act with unprecedented urgency, and that is exactly what our teams did by filing this application for molnupiravir with the FDA within 10 days of receiving the data,” said Robert M. Davis, Chief Executive Officer and President Merck. “We are grateful to the patients and investigators in our study and, of course, to our own colleagues, who have demonstrated in exemplary fashion Merck’s high scientific standards and our unwavering commitment to patients. I would also like to take this moment to applaud our colleagues in the pharmaceutical industry and our global health workers for taking up the challenge of developing drugs and vaccines to fight COVID-19 – drugs and vaccines are both for our joint efforts are essential. We look forward to working with the FDA in reviewing our application and working with other regulatory agencies as we do everything in our power to get molnupiravir to patients around the world as soon as possible. “
“We are grateful to the investigators and patients who helped us achieve this important milestone. Today’s performance would not be possible without their significant contributions. Filing with the FDA is a critical step in making molnupiravir available to people who could benefit from an oral antiviral that can be taken at home shortly after a diagnosis of COVID-19, “said Wendy Holman, chief executive officer of Ridgeback Biotherapeutics. “We are excited to be working with Merck and regulatory agencies to make molnupiravir available to the people who need it here in the US and around the world.”
About Merck’s efforts to provide access to molnupiravir when it receives an EUA or approval
Anticipating the results of MOVe-OUT and the potential for regulatory approval or approval, Merck has manufactured molnupiravir at risk and expects to produce 10 million treatment cycles by the end of 2021, with additional treatment cycles expected in 2022.
Earlier this year, Merck signed a procurement agreement with the US government under which the company will supply approximately 1.7 million molnupiravir courses to the US government upon EUA or US FDA approval. In addition, Merck has pending regulatory approval for molnupiravir with other governments around the world and is currently in discussion with other governments.
Merck is committed to providing timely access to molnupiravir worldwide, if approved or approved, and plans to introduce a tiered pricing approach based on World Bank countries ‘income criteria to reflect countries’ relative ability to fund their health response to the pandemic .
As part of its commitment to global access, Merck has already announced that it has entered into non-exclusive, voluntary molnupiravir licensing agreements with established Indian generic drug companies to increase the availability of molnupiravir in more than 100 low and middle income countries (LMICs) accelerate) after approvals or emergency clearances from local regulatory authorities.
Molnupiravir (MK-4482 / EIDD-2801) is an orally administered test form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including the prophylaxis, treatment, and prevention of transmission. In addition, preclinical and clinical data have shown that molnupiravir is effective against the most common SARS-CoV-2 variants.
Molnupiravir was invented by Drug Innovations at Emory (DRIVE), LLC, a nonprofit biotechnology company wholly owned by Emory University; Emory / DRIVE has received some research grants from the US Department of Defense and the National Institutes of Health. Molnupiravir is being developed by Merck & Co., Inc. in partnership with Ridgeback Biotherapeutics. Ridgeback has received an upfront payment from Merck and is also entitled to contingent payments based on the achievement of certain development and approval milestones. Any profits from the cooperation will be divided equally between the partners. Since it was licensed by Ridgeback, all funds used in the development of molnupiravir have been provided by Merck and by Wayne and Wendy Holman of Ridgeback.
Molnupiravir is also being investigated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled, Phase 3 study evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19. is examined within households. More information is available at http://merckcovidresearch.com.
About the MOVe-OUT study
The MOVe-OUT Study (MK-4482-002) (NCT04575597) is a global, randomized, placebo-controlled, double-blind, multi-site Phase 3 study in non-hospitalized adult patients with laboratory-confirmed mild to moderate COVID-19. Patients enrolled in the study were not vaccinated against SARS-CoV-2, had at least one risk factor associated with poor disease progression, and occurred within five days of randomization. The primary efficacy goal of MOVe-OUT is to evaluate the effectiveness of molnupiravir compared to placebo, as measured by the percentage of participants who will be hospitalized and / or die from time of randomization to day 29.
The phase 3 part of the MOVe-OUT study was conducted worldwide, including in more than 170 planned centers in countries such as Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, UK and USA. For more information on the MOVe-OUT study, visit Clinicaltrials.gov.
The most common risk factors for poor disease progression were obesity, older age (> 60 years), diabetes mellitus, and heart disease. Delta, gamma and mu variants accounted for nearly 80% of the baseline viral variants sequenced at the time of the interim analysis. Recruits in Latin America, Europe and Africa represented 56%, 23% and 15% of the study population, respectively.
About Ridgeback Biotherapeutics
Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases. Ridgeback markets EbangaTM for the treatment of Ebola and has a late-stage development pipeline that includes molnupiravir for the treatment of COVID-19. Molnupiravir development is fully funded by Ridgeback Biotherapeutics and Merck & Co., Inc. All of Ridgeback Biotherapeutics, LP’s equity comes from Wayne and Wendy Holman, who are committed to investing and supporting life-saving medical technologies. The Ridgeback team is dedicated to finding life-saving and life-changing solutions for patients and diseases that need champions.
For over 130 years, Merck, known as MSD outside of the United States and Canada, has invented inventions for life, developing drugs and vaccines for many of the world’s most difficult diseases to help fulfill our mission to save and improve lives. We demonstrate our commitment to patient and community health by improving access to health care through broad policies, programs and partnerships. Today, Merck continues to lead research into the prevention and treatment of diseases that threaten humans and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aim to be the leading research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.